Evaluation of the Protective Role of the L-DOPA Against Age Related Macular Degeneration in Parkinson's Patients

Terminated

• Conditions: Macular Degeneration, Senile
• Interventions: Device: Color retinography; Device: Optical coherence tomography; Device: Fundus autofluorescence imaging

• Registration Number: NCT02863640
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Age related macular degeneration (ARMD) is a major and irreversible cause of blindness among the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE) and the external segments of the retinal photoreceptors, plays a crucial role in this pathology. A recent epidemiologic study in the US, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.

The L-Dopa is an endogenous ligand of the GPR43 receptor, located on the RPE's cell's apical pole.

This receptor, via several intracellular mechanisms, regulates the cell's exosomal and endosomal pathways: it would appear that the L-DOPA, by stimulating this receptor, decreases significantly the RPE's exosome release.

The contents of the exosomes is still uncertain, however in addition to their signalization role, it seems they transport pro-inflammatory components, possibly helping the cellular recruitment due to the mononuclear phagocytic systems, particularly toxic for the photoreceptors.

The aim of this study is to validate the hypothesis stating that he L-DOPA would play a protective role against age related macular degeneration.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-14
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Primary Completion: 2017-12-18
• Study Completion: 2017-12-18
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Patients aged of 70 years old and more
• Parkinson's disease

Exclusion Criteria

• Opposition to participate in this trial
• Patient under a measure of legal protection
• Absence of affiliation to social security or universal health coverage (CMU)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed patients	Optical coherence tomography	Patients treated for Parkinson's disease with a cumulative dose of L-DOPA above the 59th percentile of the population
Non exposed patients	Color retinography	Patients treated for Parkinson's disease with a cumulative dose of L-DOPA below the 41th percentile of the population
Non exposed patients	Fundus autofluorescence imaging	Patients treated for Parkinson's disease with a cumulative dose of L-DOPA below the 41th percentile of the population
Exposed patients	Fundus autofluorescence imaging	Patients treated for Parkinson's disease with a cumulative dose of L-DOPA above the 59th percentile of the population
Non exposed patients	Optical coherence tomography	Patients treated for Parkinson's disease with a cumulative dose of L-DOPA below the 41th percentile of the population
Exposed patients	Color retinography	Patients treated for Parkinson's disease with a cumulative dose of L-DOPA above the 59th percentile of the population

Primary Outcome Measures

Name	Time	Method
Diagnosis of ARMD based on ophtalmological examination combining color retinography, optical coherence tomography and fundus autofluorescence Imaging	Diagnosis of ARMD made during a single consultation lasting about an hour	Risk of ARMD : Ratio between the ARMD prevalence rate in patients with an elevated cumulated dose of L-DOPA and the ARMD prevalence rate in patients with a low cumulated dose of L-DOPA Risk adjusted according to age and sexe

Trial Locations

Locations (1)

Fondation Ophtalmologique A. de Rotchschild; 🇫🇷 Paris, France